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Graft Versus Host Disease (GVHD)

Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
NCT04167514 | Phase 3 | Interventional

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

Trial Information
25 Sites
122 Participants
18 Years

If interested, contact for more information

Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32608, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322-1059, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
IU Hospital
Indianapolis, Indiana, 46202, United States
Univ. of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
UM Medical Center
Ann Arbor, Michigan, 48109-0312, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
Saint Louis, Missouri, 63110, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
New York, New York, 10065, United States
Levine Cancer Center
Charlotte, North Carolina, 28204, United States
Durham, North Carolina, 27705, United States
Cleveland Clinic
Cleveland, Ohio, 44124, United States
Ohio State Univ.Medical Center
Columbus, Ohio, 43210, United States
Center for Gene Therapy
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Commonwealth Univ.
Richmond, Virginia, 23298, United States
Fred Hutchinson Clinic
Seattle, Washington, 98109, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States

Study Eligibility Criteria

  • Patients 18 years of age or older
  • Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
  • Any graft or donor source or conditioning intensity
  • Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids
  • Prior exogenous AAT exposure for GVHD prophylaxis
  • Relapsed, progressing, or persistent malignancy
  • de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
  • Receiving other drugs for the treatment of GVHD
  • Receiving systemic CS for any indication within 7 days before the onset of acute GVHD

Additional Studies

Additional studies can be found at